Trial Outcomes & Findings for Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea (NCT NCT02196675)
NCT ID: NCT02196675
Last Updated: 2016-07-15
Results Overview
Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
Recruitment status
COMPLETED
Target enrollment
105 participants
Primary outcome timeframe
Post-operative period through hospital discharge and follow-up at Day 30
Results posted on
2016-07-15
Participant Flow
Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.
There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.
Participant milestones
| Measure |
Wedge Resection
Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
|
Lobectomy
Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
|
Wedge Resection With Lobectomy
Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
70
|
8
|
|
Overall Study
COMPLETED
|
25
|
68
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Wedge Resection
Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
|
Lobectomy
Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
|
Wedge Resection With Lobectomy
Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Intra-operative surgical exclusion
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
Baseline characteristics by cohort
| Measure |
Wedge Resection
n=26 Participants
Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
|
Lobectomy
n=69 Participants
Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
|
Wedge Resection With Lobectomy
n=8 Participants
Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 10.41 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
26 participants
n=5 Participants
|
69 participants
n=7 Participants
|
8 participants
n=5 Participants
|
103 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
Outcome measures
| Measure |
Wedge Resection
n=26 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=69 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Occurrence of Prolonged Air Leaks
|
0.0 percentage of participants
Interval 0.0 to 13.2
|
5.8 percentage of participants
Interval 1.6 to 14.2
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
Outcome measures
| Measure |
Wedge Resection
n=26 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=69 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Occurrence of Postoperative Air Leaks
|
30.8 percentage of participants
Interval 14.3 to 51.8
|
42.0 percentage of participants
Interval 30.2 to 54.5
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
SECONDARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.
Determined as the length of time in days from hospital admission to initial hospital discharge
Outcome measures
| Measure |
Wedge Resection
n=25 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=69 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Length of Stay (LOS)
|
7.2 days
Standard Deviation 2.95
|
9.3 days
Standard Deviation 4.07
|
9.4 days
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Blood loss intra-op and up to 5 days post-opPopulation: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Outcome measures
| Measure |
Wedge Resection
n=26 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=69 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Volume of Estimated Intra-operative Blood Loss
|
30.4 milliliters
Standard Deviation 40.27
|
146.1 milliliters
Standard Deviation 155.96
|
91.3 milliliters
Standard Deviation 124.95
|
SECONDARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.
Outcome measures
| Measure |
Wedge Resection
n=26 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=69 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Time to Chest Tube Removal
|
3.4 days
Standard Deviation 1.63
|
5.2 days
Standard Deviation 1.97
|
6.3 days
Standard Deviation 2.38
|
Adverse Events
Wedge Resection
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Lobectomy
Serious events: 9 serious events
Other events: 43 other events
Deaths: 0 deaths
Wedge Resection With Lobectomy
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wedge Resection
n=27 participants at risk
Subjects undergoing VATS wedge resection
|
Lobectomy
n=70 participants at risk
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 participants at risk
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
General disorders
Pyrexia
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
4.3%
3/70 • Number of events 3 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
37.5%
3/8 • Number of events 3 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
Other adverse events
| Measure |
Wedge Resection
n=27 participants at risk
Subjects undergoing VATS wedge resection
|
Lobectomy
n=70 participants at risk
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=8 participants at risk
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
24.3%
17/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
25.0%
2/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
3/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
7.1%
5/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
25.0%
2/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Nausea
|
44.4%
12/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
21.4%
15/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Investigations
Liver function test abnormal
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
2/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Nervous system disorders
Dizziness
|
14.8%
4/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
5.7%
4/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Renal and urinary disorders
Dysuria
|
7.4%
2/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
1.4%
1/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Renal and urinary disorders
Urinary retention
|
7.4%
2/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
4.3%
3/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
10.0%
7/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
25.0%
2/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/27 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
10.0%
7/70 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
12.5%
1/8 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission for publication or presentation, the Institution will provide Sponsor with at least sixty (60) days for review of a manuscript. Notwithstanding the foregoing, no paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER